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Wall Street looked set to open little changed on Tuesday after the Christmas holiday weekend, even as the Dow Jones industrial average inches towards 20,000. Small gains in oil prices supported futures. U.S. crude was up 0.4 percent at $53.24, while Brent crude steadied at $55 as a deal to limit supply came into effect on Sunday, boosting expectations of higher prices. A report is expected to show that the consumer confidence index rose to 109 in December, after hitting 107.1 the previous month. The data is due at 10:00 a.m. ET (1500 GMT). Global markets made small gains on data that showed Chinese industry racked up its strongest profit growth in three months in November, suggesting the world’s second-largest economy was improving.
Seattle Genetics announced that it has received notice from the FDA that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials. The Phase I/II trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold. Two Phase I trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent). These studies are SGN-CD33A monotherapy, including a subset of older AML patients in combination with hypomethylating agents, and SGN-CD33A combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients. No new studies will be initiated until the clinical holds are lifted. Seattle Genetics’ other ongoing trials of SGN-CD33A, including the phase 3 CASCADE trial in older AML patients and Phase I/II trial in myelodysplastic syndrome, are proceeding with enrollment.
Protalix BioTherapeutics announced the confirmation of the recent letter of intent to purchase alfataliglicerase to treat Gaucher patients in Brazil by the Brazilian Ministry of Health. The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $24.3 million. Shipments are to start in mid-2017 and continue through the end of the year, in increasing volumes. The size of the final shipment of this order represents annual revenues of approximately $42 million.
Ionis Pharmaceuticals announced that the FDA has approved SPINRAZA (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness. SPINRAZA was discovered and developed by Ionis and Biogen, and licensed to Biogen who is responsible for future development, manufacturing, and commercialization of SPINRAZA. In ENDEAR, a pivotal controlled clinical study, infantile-onset SMA patients treated with SPINRAZA achieved and sustained clinically meaningful improvement in motor function compared to untreated study participants. In addition, a greater percentage of patients on SPINRAZA survived compared to untreated patients. In open-label studies, some patients achieved milestones such as ability to sit unassisted, stand or walk when they would otherwise be unexpected to do so and maintained milestones at ages when they would be expected to be lost. The overall findings of these studies support the effectiveness of SPINRAZA across the range of SMA patients, and appear to support the early initiation of treatment. Following the news, Leerink analyst Geoffrey Porges increased his price target of Biogen to $368 from $355; Leerink analyst Paul Matteis increased his price target of Ionis to $47 from $40; Morgan Stanley analyst David Lebowitz increased his price target of Ionis to $43 from $40; Janney analyst Debjit Chattopadhyay increased his fair value estimate of Ionis to $54 from $50.
Apricus Biosciences announced the launch of Vitaros, Apricus’ novel on-demand topical cream for the treatment of erectile dysfunction ("ED"), in Lebanon by Elis Pharmaceuticals.
Immunomedics announced that a single-arm Phase II study with sacituzumab govitecan (IMMU-132) has achieved the planned enrollment of 100 patients with metastatic triple-negative breast cancer (TNBC) who have received more than one prior therapy for their metastatic disease.
Shire announced that the FDA has approved ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved ADYNOVATE for use in surgical settings for both adult and pediatric patients. ADYNOVATE is built on the full-length ADVATE [Antihemophilic Factor (Recombinant)] molecule, a market leading treatment for hemophilia A with more than 13 years of real-world patient experience.
Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, announced that new data on the use of Vectra DA test to predict treatment response in patients with rheumatoid arthritis (RA) published online in the journal Arthritis & Rheumatology.
Rasna Therapeutics announced that it has closed a private placement to accredited investors of an aggregate 3,366,667 shares of common stock at $0.60 per share for gross proceeds of $2.02 million. The Company intends to use the proceeds for clinical development and working capital.
Mylan and Biocon announced that the results of the HERITAGE study have been published in the Journal of the American Medical Association (JAMA). Study results confirm the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab. The results of the trial were first presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress. Branded trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers.
IntelGenx announced that it has entered into a co-development and commercialization agreement with Endo Ventures for a new product utilizing IntelGenx’ proprietary VersaFilm for the USA market. Under the agreement, Endo has obtained certain exclusive rights to market and sell IntelGenx’ product in the USA. IntelGenx will receive an upfront payment and future milestone payments. Endo and IntelGenx will share the profits of commercialization.
Biocept announced that Columbia University Medical Center will conduct a study to evaluate the clinical utility of the Company’s Target Selector platform to diagnose leptomeningeal metastases (LM) in patients with breast cancer. LM occurs when tumor cells gain access to cerebrospinal fluid (CSF) pathways and regrow in distant sites within the spinal cord and brain leading to neurological complications. Biocept’s liquid biopsy platform will be used to test the CSF of breast cancer patients and will be compared to standard methods for confirming the diagnosis of LM.
Capnia and privately-held Essentialis announced their entry into a definitive merger agreement to create a rare disease therapeutics company. The combined company will be well-positioned to advance diazoxide choline controlled release tablet (DCCR), a once-daily oral tablet for the treatment of patients with Prader-Willi syndrome (PWS). PWS is a rare complex genetic neurobehavioral/metabolic disease. The clinical features of the disease include hyperphagia (unrelenting hunger), as well as metabolic, endocrine, cognitive and behavioral complications resulting in significant morbidity and premature death. Upon closing of the merger, Capnia expects to issue shares of common stock at $0.96 per share to a syndicate comprised of current and new investors for gross proceeds of $8.0 million. These funds would be used to execute a planned Phase II/III clinical study evaluating the efficacy and safety of DCCR for the treatment of patients with PWS. This study is expected to commence in the second half of 2017.
Amphastar Pharmaceuticals announced that the FDA issued a CRL to its wholly-owned subsidiary, Armstrong Pharmaceuticals, for its NDA for Primatene Mist (epinephrine inhalation aerosol).
Credit Suisse analyst Vamil Divan increased his price target of Portola Pharmaceuticals to $29 from $20, citing FDA acceptance of the NDA and EMA validation of the Marketing Authorization for betrixaban for use in acute medically ill patients. Citi analyst Yigal Nochomovitz upgraded the company to “buy” from “neutral” and increased his price target to $32 from $24.
HC Wainwright analyst Ed Arce increased his price target of Akebia Therapeutics to $18 from $17, citing the collaboration deal with Otsuka Pharmaceutical Co. to develop and commercialize vadadustat in the U.S.
FBR analyst Ed White increased his price target of TESARO to $151 from $133, citing an updated model to reflect the 4Q16 raise.